These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

226 related articles for article (PubMed ID: 22130775)

  • 1. Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA.
    Liu Q; Davit BM; Cherstniakova SA; Dandamudi S; Walters JF; Lee CH; Raines KW; Ren K; Williamson LN; Conner DP
    AAPS J; 2012 Mar; 14(1):19-22. PubMed ID: 22130775
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Common bioanalytical deficiencies with bioequivalence submissions in Abbreviated New Drug Applications.
    Williamson LN; Conner DP; Stier EM; Davit BM
    Bioanalysis; 2014 Feb; 6(4):441-5. PubMed ID: 24568348
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Common Deficiencies of in vitro Binding Bioequivalence (BE) Studies Submitted in Abbreviated New Drug Applications (ANDAs).
    Lu D; Vivian D; Ren P; Yang Y; Zhang H; Jiang X; Stier E
    AAPS J; 2018 Jan; 20(2):26. PubMed ID: 29327295
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Applications of In Vitro-In Vivo Correlations in Generic Drug Development: Case Studies.
    Kaur P; Jiang X; Duan J; Stier E
    AAPS J; 2015 Jul; 17(4):1035-9. PubMed ID: 25896303
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies.
    Fermaglich LJ; Chen R; Kim CY; Chuh EE; Thomas T; Shetty D; Lee J; Young J; Fan Y
    Ther Innov Regul Sci; 2019 Jan; 53(1):81-85. PubMed ID: 29719976
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions.
    Wittayanukorn S; Rosenberg M; Schick A; Hu M; Wang Z; Babiskin A; Lionberger R; Zhao L
    Ther Innov Regul Sci; 2020 Nov; 54(6):1372-1381. PubMed ID: 32495310
    [TBL] [Abstract][Full Text] [Related]  

  • 7. United States Food and Drug Administration requirements for approval of generic drug products.
    Meyer MC
    J Clin Psychiatry; 2001; 62 Suppl 5():4-9; discussion 23-4. PubMed ID: 11305846
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications.
    Davit BM; Conner DP; Fabian-Fritsch B; Haidar SH; Jiang X; Patel DT; Seo PR; Suh K; Thompson CL; Yu LX
    AAPS J; 2008; 10(1):148-56. PubMed ID: 18446515
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
    Davit BM; Nwakama PE; Buehler GJ; Conner DP; Haidar SH; Patel DT; Yang Y; Yu LX; Woodcock J
    Ann Pharmacother; 2009 Oct; 43(10):1583-97. PubMed ID: 19776300
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process.
    Kesselheim AS; Gagne JJ; Franklin JM; Eddings W; Fulchino LA; Campbell EG
    Pharmacoepidemiol Drug Saf; 2017 Jun; 26(6):694-701. PubMed ID: 28370652
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Generic substitution: issues for problematic drugs.
    Henderson JD; Esham RH
    South Med J; 2001 Jan; 94(1):16-21. PubMed ID: 11213935
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective.
    Liu Q; Absar M; Saluja B; Guo C; Chowdhury B; Lionberger R; Conner DP; Li BV
    AAPS J; 2019 Jan; 21(2):14. PubMed ID: 30617594
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA).
    Moeti L; Litedu M; Joubert J
    Ther Innov Regul Sci; 2022 Sep; 56(5):822-838. PubMed ID: 35896784
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Assessment of Manufacturing Related Deficiencies for Modified Release Tablet in Abbreviated New Drug Applications.
    Chen J; Wang Z; Shah R; Scherlitz A; Feng X; Chen J; Wu L
    AAPS PharmSciTech; 2022 Sep; 23(7):268. PubMed ID: 36168006
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs.
    Li Z; Fang L; Jiang W; Kim MJ; Zhao L
    Curr Neurol Neurosci Rep; 2017 Sep; 17(11):82. PubMed ID: 28929357
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USA.
    Nair AK; Anand O; Chun N; Conner DP; Mehta MU; Nhu DT; Polli JE; Yu LX; Davit BM
    AAPS J; 2012 Dec; 14(4):664-6. PubMed ID: 22718306
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs).
    Raw AS; Furness MS; Gill DS; Adams RC; Holcombe FO; Yu LX
    Adv Drug Deliv Rev; 2004 Feb; 56(3):397-414. PubMed ID: 14962589
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.
    Davit BM; Chen ML; Conner DP; Haidar SH; Kim S; Lee CH; Lionberger RA; Makhlouf FT; Nwakama PE; Patel DT; Schuirmann DJ; Yu LX
    AAPS J; 2012 Dec; 14(4):915-24. PubMed ID: 22972221
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Dissolution testing for generic drugs: an FDA perspective.
    Anand O; Yu LX; Conner DP; Davit BM
    AAPS J; 2011 Sep; 13(3):328-35. PubMed ID: 21479700
    [TBL] [Abstract][Full Text] [Related]  

  • 20. A review of the safety of generic drugs.
    Dighe SV
    Transplant Proc; 1999 May; 31(3A Suppl):23S-24S. PubMed ID: 10330955
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 12.